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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVEVE, INC. GENEVEVE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

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VIVEVE, INC. GENEVEVE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burning Sensation (2146); Numbness (2415)
Event Date 03/23/2017
Event Type  Injury  
Event Description
I received the geneveve treatment which is a rf device vaginal rejuvenation treatment made by viveve, inc. Within a few days of the treatment, my vagina felt numb and still does. It also has a constant burning sensation near the internal area right past my introitus. It's been 16 months and i no longer enjoy vaginal intercourse because of the numb sensation and constant burning feeling. They promote it for vaginal rejuvenation, laxity, dryness and desire.
 
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Brand NameGENEVEVE
Type of DeviceELECTROSURGICAL CUTTING AND COAGULATION DEVICE
Manufacturer (Section D)
VIVEVE, INC.
MDR Report Key7742801
Report NumberMW5078794
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Age53 YR
Patient Weight52
Patient Outcome(s) Other;
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